Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: QIH ×
334 results
49–72 of 334
Search insights Median review: 139d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 30, 2026
Synapse 3D Base Tools (V7.2)
K254189 · QIH
Fujifilm Corporation
Radiology · 128d
Cleared Apr 29, 2026
syngo Application Software
K254184 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 127d
Cleared Apr 23, 2026
DS Core CBCT Anatomy
K260785 · QIH
Dentsply Sirona
Radiology · 44d
Cleared Apr 22, 2026
uOmnispace.MR
K253077 · QIH
Shanghai United Imaging Healthcare...
Radiology · 211d
Cleared Apr 20, 2026
Folliscan
K252332 · QIH
Mim Fertility
Radiology · 269d
Cleared Apr 14, 2026
Critical Care Suite with Enteric Tube Positioning AI Algorithm
K253502 · QIH
Ge Medical Systems, LLC
Radiology · 166d
Cleared Apr 10, 2026
Relu Cloud
K252708 · QIH
Relu BV
Dental · 226d
Cleared Apr 10, 2026
syngo Dynamics (VA41F)
K253689 · QIH
Siemens Healthcare GmbH
Radiology · 140d
Cleared Apr 10, 2026
Overjet Iris Intelligent Imaging System
K253930 · QIH
Overjet, Inc.
Radiology · 122d
Cleared Apr 01, 2026
CoLumbo C-Spine
K254015 · QIH
Smart Soft Healthcare AD
Radiology · 107d
Cleared Mar 26, 2026
SwiftMR
K253775 · QIH
Airs Medical, Inc.
Radiology · 120d
Cleared Mar 17, 2026
EchoNavigator R5.0
K253614 · QIH
Philips Medical Systems Nederland B.V.
Radiology · 119d
Cleared Mar 16, 2026
Data Analysis Facilitation Suite (DAFS)
K253944 · QIH
Voronoi Health Analytics Incorporated
Radiology · 96d
Cleared Mar 13, 2026
InferCare RECIST
K252261 · QIH
Beijing Infervision Healthcare...
Radiology · 235d
Cleared Mar 06, 2026
VELYS™ Hip Navigation
K253551 · QIH
Depuy Ireland UC
Radiology · 112d
Cleared Mar 05, 2026
CEPHX3D
K252538 · QIH
Orca Dental AI , Ltd.
Radiology · 205d
Cleared Mar 02, 2026
Clarius Ejection Fraction AI
K253593 · QIH
Clarius Mobile Health Corp.
Radiology · 105d
Cleared Feb 27, 2026
Ligence Heart
K253535 · QIH
Ligence Uab
Radiology · 106d
Cleared Feb 24, 2026
AI Platform 2.2 (AIP002)
K260217 · QIH
Exo Imaging
Radiology · 32d
Cleared Feb 11, 2026
AI4CMR v2.0
K252084 · QIH
Ai4medimaging Medical Solutions S.A.
Radiology · 224d
Cleared Feb 10, 2026
MI View&GO
K254016 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Jan 29, 2026
Surgical Reality Viewer
K252091 · QIH
Medicalvr B.V.
Radiology · 210d
Cleared Jan 29, 2026
Neurophet AQUA AD Plus
K252496 · QIH
Neurophet., Inc.
Radiology · 174d
Cleared Jan 22, 2026
AI-Rad Companion Brain MR
K253057 · QIH
Siemens Healthcare GmbH
Radiology · 122d